1. Technical Field
The present disclosure is directed to system(s) and method(s) for sterilization of products and/or systems using UV light source(s). More particularly, the present disclosure is directed to system(s) and method(s) for sterilization of polymer-based products, whether positioned within or external to their packaging, using monochromatic, continuous wave, high-intensity, incoherent light in single and/or multiple light source configurations. The disclosed treatment system(s) and method(s) advantageously preserve physical and performance properties of the product/system while achieving a desired level of sterilization. The disclosed treatment system(s) and method(s) may be used for sterilization of alternative products, including, for example, food products such as meat and poultry, enteral and/or parenteral solutions and systems, and the like.
2. Background Art
Sterilization is generally defined as the complete destruction of all organisms, including a large number of highly resistant bacterial endospores. A host of sterilization techniques have been developed to address specific sterilization needs. Typical sterilization techniques include the use of moist heat from a steam autoclave, ethylene oxide gas sterilizing techniques, dry heat techniques, and newer chemical sterilizers.
Steam sterilization is widely used and is generally viewed as relatively cost-effective sterilization technique. The use of steam sterilization techniques employing an autoclave is recognized as an efficient, simple, and relatively cost-effective approach for destroying all relevant organisms. However, certain components (e.g., medical device/instrumentation components and accessories) cannot endure the extremes of heat and pressure. For example, steam and pressure are known to damage rubber, Lexan® plastic components, and other synthetic materials, and the use of a steam autoclave for any anesthesia equipment is generally not recommended, unless the treatment method is specifically recommended by the manufacturer.
Ethylene oxide is acceptable for many materials used in manufacturing medical devices and the like, including the reusable components of anesthesia machines, ventilators, and monitors. However, it is generally inappropriate to place these entire systems in an ethylene oxide chamber. In addition, polystyrene component parts cannot be exposed to ethylene oxide gas. Ethylene oxide sterilization employs a powerful poisonous fumigant gas, and therefore mandates an appropriate means of aeration to remove all traces of residual gas. Workers exposed to ethylene oxide are required to comply with all procedures specified by OSHA and the EPA. Alternative chemical treatment techniques include the use of hydrogen peroxide and peroxyacetic acid with buffers and low heat.
More recently, a sterilization technique was disclosed in U.S. Pat. No. 5,786,598 to Clark et al., entitled “Sterilization of Packages and Their Contents Using High-Intensity, Short-Duration Pulses of Incoherent, Polychromatic Light in a Broad Spectrum.” As noted in the title, the Clark '598 patent involves the use of high-intensity, short-duration pulses of incoherent, polychromatic light in a broad spectrum to sterilize product containers and deactivate microorganisms therein. The Clark '598 proposes “the deactivation of microorganisms within parenteral and/or enteral solutions and packages or within contact lens solutions and packages and/or ophthalmic solutions and packages.” [See col. 1, lines 11–20.] The use of short-duration pulses of incoherent, polychromatic light in a broad spectrum, as disclosed in the Clark '598 patent, is believed to be ineffective and/or unacceptable for at least some aspects of the proposed applications.
Despite efforts to date, a need remains for system(s) and/or method(s) for use in sterilizing polymer-based product(s), whether positioned within or external to their packaging, wherein such treatment regimen achieves a desired sterilization level without negatively affecting the physical properties and/or the efficacy of the underlying polymer-based product(s). A need also exists for system(s) and/or method(s) for use in sterilizing alternative products (e.g., food products such as meat and poultry, enteral and/or parenteral solutions and systems, and the like), whether positioned within or external to their packaging, wherein such treatment regimen achieves a desired sterilization level without negatively affecting the physical properties and/or the efficacy of the underlying product(s).
These and other objectives are satisfied according to the present disclosure wherein sterilization is achieved using monochromatic, continuous wave, high-intensity, incoherent light in single and/or multiple light source configurations. The disclosed treatment system(s) and method(s) advantageously achieve a desired sterilization level without negatively affecting the physical properties and/or the efficacy of the underlying product(s). These and other features/functionalities will be apparent to persons skilled in the art from the detailed description which follows.